# K243081: Green X 21  (PHT-90CHO)

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Feb 14, 2025 after 137 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K973642 (1997). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210329: Green X 18(Model : PHT-75CHS), VATECH Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K260093: Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (2026), 0 descendants of its own

## Indications for use
Green X 21 (Model: PHT-90CHO) is intended to produce panoramic, cephalometric, or 3D digital X-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, TMJ, and ENT for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

Source page: https://510kreport.com/device/K243081
Methodology: https://510kreport.com/methodology